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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K033159
Device Name LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05
Applicant
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact BRIAN K KEOGH
Correspondent
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact BRIAN K KEOGH
Regulation Number870.4450
Classification Product Code
MJN  
Date Received09/30/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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